Clinical Trial: A Feasibility Study to Evaluate the Safety and Short-term Effectiveness of Transcatheter Pulmonary Valve (TPV)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Feasibility Study to Evaluate the Safety and Short-term Effectiveness of Implantation of Transcatheter Pulmonary Valve (TPV) for the Treatment of Congenital Heart Disease With Pulmonary Valve Diseas

Brief Summary: The purpose of this study is to evaluate the safety and short-term effectiveness of implantation of Transcatheter Pulmonary Valve (TPV) for the treatment of congenital heart disease with pulmonary valve disease.

Detailed Summary: Diverse congenital heart diseases involving the pulmonary artery, such as Tetralogy of Fallot (TOF) with or without pulmonary atresia, or transposition of the great arteries with pulmonary stenosis, require implantation of an artificial conduit between the right ventricle and the pulmonary artery(PA). Because these conduits finally degenerate and result in pulmonary regurgitation and/or stenosis and progressive right ventricle (RV) dilation and eventual failure, patients need repetitive surgery for conduit revision. Transcatheter pulmonary valve implantation (TPVI) is a less invasive alternative to surgery in patients with dysfunctional right ventricular outflow tract (RVOT). TPV is a large-diameter (up to 28 mm) self-expandable stent with a relatively low profile from a nitinol wire backbone with valve leaflets made from porcine pericardial tissue. The TPV is indicated for use in patients with previous undergone replacement of bioprosthetic valve or conduit due to either pulmonary valve atresia, stenosis, regurgitation or a combination of them and present with dysfunctional RVOT requiring treatment for severe pulmonary regurgitation and/or RVOT conduit obstruction. Consecutive subject data should be collected at discharge, 1, 3, 6 month, and 1-5 years post TPV implantation.
Sponsor: Seoul National University Hospital

Current Primary Outcome:

  • Procedural success [ Time Frame: 5day ]
    Procedural success is defined as the TPV implant within desired position, RV-PA peak systolic pressure gradient <35mmHg by catheter, less mild pulmonary regurgitation by angiography, and freedom from explantation of the TPV at 24 hours post-implant.
  • Hemodynamic functional improvement at 6month [ Time Frame: 6 month ]
    Hemodynamic functional improvement is defined as mean RVOT gradient ≤30 mmHg by continuous wave doppler, and a pulmonary regurgitant fraction <20% by cardiac magnetic resonance (MR).
  • Procedural / Device related serious adverse events at 6month [ Time Frame: 6 month ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Hemodynamic function [ Time Frame: 5 year ]
    Hemodynamic function will be measured including peak RVOT pressure gradient, mean RVOT pressure gradient, RV-PA pressure gradient, RV pressure, cardiac output, cardiac index, RV end-diastolic volume by echocardiography, cardiac MR, or catheterization.
  • Severity of pulmonary regurgitation [ Time Frame: 5year ]
  • Pulmonary regurgitant fraction [ Time Frame: 5year ]
  • New York Heart Association (NYHA) functional classification [ Time Frame: 5 year ]
  • Stent fracture [ Time Frame: 5 year ]
  • Catheter reintervention on TPV [ Time Frame: 5 year ]
  • Reoperation [ Time Frame: 5 year ]
  • Procedural / Device related serious adverse events [ Time Frame: 5 year ]
  • Death (all cause / procedural / device-related) [ Time Frame: 5 year ]
  • Other adverse events [ Time Frame: 5 year ]


Original Secondary Outcome: Same as current

Information By: Seoul National University Hospital

Dates:
Date Received: September 9, 2015
Date Started: September 2015
Date Completion: October 2021
Last Updated: April 6, 2017
Last Verified: April 2017